Immune Drugs for Moderately or Severely Sick Hospital COVID-19 Patients
Protocol: STUDY00005380
Full Title
ACTIV 1: Randomized Master Protocol for Immune Modulators for Treating COVID-19
This study enrolls adults who have tested positive for COVID-19 and are currently hospitalized at Buffalo General Hospital or Millard Fillmore Hospital. The purpose is to learn whether immune study drugs that target inflammation can help with symptoms and recovery from COVID-19. 75% of the participants will receive study drug and 25% will receive placebo (no active ingredients). Neither the doctors or you will know which study drug or placebo you will receive. The study drug will either be : one time infliximab (Remicade) infusion in vein, one time abatacept (Orencia) infusion in vein, or 28 days of cenicriviroc (CVC) tablets. Most participants will also receive the anti-viral Remdesivir infusion in vein for maximum of 10 days. The study will last for about 60 days.

Technical Description

(CSR 210351912303) ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent wi

Keyword: COVID-19
Compensation: No
Admitted to Buffalo General or Millard Fillmore Suburban or awaiting admission in the ED with symptoms suggestive of COVID-19.
Male or non-pregnant female adults ≥18 years of age at time of enrollment.
Has laboratory-confirmed (within 14 days prior to enrollment) SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen.
Ongoing illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- Blood oxygen saturation (SpO2) ≤ 94% on room air, OR
- Requiring supplemental oxygen, OR
- Requiring mechanical ventilation or ECMO.
Age Group: Adults
Principal Investigator: MANOJ MAMMEN Open Study
Janice Wolfman
Want to Learn More?
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